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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031198
Receipt No. R000035624
Scientific Title Predictive value of preoperative inflammation-related factors for postoperative analgesic consumption in patients with inflammatory bowel syndrome: a retrospective observational study.
Date of disclosure of the study information 2018/02/28
Last modified on 2019/02/10

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Basic information
Public title Predictive value of preoperative inflammation-related factors for postoperative analgesic consumption in patients with inflammatory bowel syndrome: a retrospective observational study.
Acronym Predictive value of preoperative inflammation for postoperative analgesic consumption in IBD patients.
Scientific Title Predictive value of preoperative inflammation-related factors for postoperative analgesic consumption in patients with inflammatory bowel syndrome: a retrospective observational study.
Scientific Title:Acronym Predictive value of preoperative inflammation for postoperative analgesic consumption in IBD patients.
Region
Japan

Condition
Condition Inflammatory Bowel Syndrome
Classification by specialty
Gastrointestinal surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the relationship between preoperative inflammation and postoperative consumption of fentanyl given by intravenous patient-controlled analgesia in patients with inflammatory bowel syndrome.
Basic objectives2 Others
Basic objectives -Others Analgesic consumption.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative consumption of fentanyl given by intravenous patient-controlled analgesia (24, 48, and 72 hours after surgery).
Key secondary outcomes Postoperative outcomes (complications, recovery, length of stay)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Underwent laparotomy for inflammatory bowel syndrome.
Used intravenous fentanyl for patient-controlled postoperative analgesia.
Have temporal recording of postoperative analgesic consumption.
Have electronic perioperative medical records.
Key exclusion criteria Hepatic failure
Renal failure
Hematological disease
Unable to use patient-controlled analgesia
Under preoperative influence of narcotics
Unwilling to participate
Defect in medical records
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sayaka Tsuboi
Organization Yokohama Municipal Citizens' Hospital
Division name Department of Anesthesia
Zip code
Address 56 Okazawachou, Hodogaya, Yokohama, Kanagawa, 240-8555
TEL 045-331-1961
Email stsuboi-cu@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Gaku Inagawa
Organization Yokohama Municipal Citizens' Hospital
Division name Department of Anesthesia
Zip code
Address 56 Okazawachou, Hodogaya, Yokohama, Kanagawa, 240-8555
TEL 045-331-1961
Homepage URL
Email yokohama.city.anesth@gmail.com

Sponsor
Institute Department of Anesthesia,
Yokohama Municipal Citizens' Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 横浜市立市民病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To determine the relationship between preoperative inflammation and postoperative consumption of fentanyl given by intravenous patient-controlled analgesia in patients with inflammatory bowel syndrome.

Management information
Registered date
2018 Year 02 Month 08 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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